BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.47MM X 30.3MM SPIRAL ROUTER

    MDR report key: 3984138 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-15863
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    June 25, 2012
    Report Date
    August 10, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROGRESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT 1 OF 3. REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE HAD DEBRIS IN THE STERILE PACKAGING. IT IS KNOWN THAT THE DEVICE WAS NOT USED IN SURGERY. IT IS ALSO KNOWN THAT THERE WAS NO PATIENT/USER INJURY OR MEDICAL INTERVENTION. IF ANY ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, THIS NOTIFICATION WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663110 2.47MM X 30.3MM SPIRAL ROUTER HBC DEPUY SYNTHES POWER TOOLS E513058747

    Patients

    Seq Age Sex Outcome Treatment
    1